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Several companies are now testing their own variations of fecal
microbiota transplantation (FMT) in a race to market a treatment for
a stubborn bacterial infection that kills 29,000 Americans every
year.
Cambridge, Massachusetts-based Seres Therapeutics Inc and Roseville,
Minnesota-based Rebiotix Inc have begun late-stage trials of their
respective treatments, with the latter company aiming to launch a
product by the middle of 2019.
"It's like getting a 'flu shot," said Rebiotix Chief Executive Lee
Jones, referring to her company's enema therapy.
First documented centuries ago in China, the concept of replenishing
a patient's gut with bacteria from a healthy stool has been used in
the United States only since the 1950s, with little regulation,
according to the Fecal Transplant Foundation.
In 2013, the U.S. Food and Drug Administration sanctioned FMT as a
last-resort therapy for recurrent strains of C. diff, or clostridium
difficile infection - an infection common in U.S. hospitals that in
some cases has grown resistant to antibiotics.
The FDA still considers FMT an "investigational treatment" pending
further research into its safety and effectiveness.
Duff, who founded the Fecal Transplant Foundation, said no doctor in
her home state of Indiana would administer treatment when she
contracted the antibiotic-resistant strain in 2012. Too sick to
travel, she and her husband took matters into their own hands.
After his stool was cleared as healthy, he mixed a sample with
saline, put it in a blender and administered it by enema. Four hours
later, Duff was able to get dressed and walk downstairs - something
she hadn't done for "months and months."
"It's a very simple procedure," she said. "The major barriers to
people doing it are finding the right donor and, I guess, what you
call the 'ick' factor."
'EVERY DONOR IS DIFFERENT'
For now, FMT requires a stool sample to be screened, liquefied and
delivered to the colon by nasal or rectal tube. Multiple studies
have shown the technique to be largely successful in preventing
relapses, following antibiotic therapy.
Patients must either find their own donor, as Duff did, or turn to a
stool bank. According to the Fecal Transplant Foundation, fewer than
3 percent of the population qualify as a healthy donor.
"Every donor is different. Every center preparing fecal transplants
is different," said David Cook, head of research and development at
Seres. "It doesn't undergo the kind of rigorous checks for quality
control that a modern pharmaceutical does."
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Partly to sidestep the "ick" factor, Seres and two other
Massachusetts-based companies, Finch Therapeutics and Crestovo LLC,
are developing a pill to deliver FMT - a solution that would
eliminate the cost and risk of a colonoscopy.
Seres' treatment missed its main goal in a mid-stage study but,
after tweaking its original design, the company initiated a
late-stage trial in June. Crestovo and Finch expect results next
year from mid-stage trials of their oral treatments.
Finch Chief Executive Mark Smith said capsules would also be "easier
to scale for patients."
The potential market is large: half a million instances of C. diff
infection are recorded every year in the United States, with 85,000
to 110,000 patients likely to experience a relapse, according to
Seres.
Research firm GlobalData forecasts that the potential market size
for C. diff treatments in seven key markets - the United States,
Britain, France, Germany, Italy, Spain and Japan - will rise to
almost $1.7 billion by 2026 from $630 million last year.
Smith said he expected new therapies to be priced competitively with
existing C. diff antibiotics, such as Merck & Co's Dificid.
From autism to obesity, the potential also exists for FMT to treat
other conditions. Nearly 200 clinical trials of the treatment in
various forms are under way.
"I don't think anyone has it quite nailed yet," said James Burgess,
co-founder of non-profit stool bank OpenBiome. "But many of the
hypotheses that are emerging seem reasonable."
(Reporting by Natalie Grover in Bengaluru; Additional reporting by
Manas Mishra and Tamara Mathias; Editing by Robin Paxton)
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